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IEC 60601-1-2 EMC Risks Testing

Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests

IEC 60601-1-2 Introduction:

The need for establishing specific standards for basic safety and essential performance with regard to electromagnetic disturbances for medical electrical equipment and medical electrical systems is well recognized.

The requirements and tests specified by IEC 60601 1 2 and EN 60601 1 2 testing are generally applicable to medical electrical equipment and medical electrical systems as defined in 3.63 and 3.64 in the general standard. For certain types of medical electrical equipment and medical electrical systems, these requirements might need to be modified by the special requirements of a particular standard.

Writers of particular standards are encouraged to refer to Annex D for guidance in the application of this collateral standard. medical electrical equipment and medical electrical systems are expected to provide their basic safety and essential performance without interfering with other equipment and systems in the electromagnetic environments in which they are intended by their manufacturer to be used. The application of electromagnetic emission standards is essential for the protection of:

  • safety services;
  • other medical electrical equipment and medical electrical systems;
  • non-medical electronic equipment (e.g. computers);
  • telecommunications (e.g. radio/TV, telephone, radio-navigation).

Of even more importance, the application of electromagnetic immunity standards is essential to ensure safety of medical electrical equipment and medical electrical systems. To ensure safety, medical electrical equipment and medical electrical systems are expected to provide their basic safety and essential performance in the electromagnetic environments of intended use throughout their expected service life.

IEC 60601-1-2 testing specifies immunity test levels for safety for medical electronic equipment and medical equipment systems intended by their manufacturer for use in the professional healthcare facility environment or the home healthcare environment. It recognizes that RF wireless communications equipment can no longer be prohibited from most patient environments because in many cases it has become essential to the efficient provision of healthcare. EN 60601-1-2 testing also recognizes that, for certain special environments, higher or lower immunity test levels than those specified for the professional healthcare facility environment and the home healthcare environment might be appropriate. This collateral standard provides guidance in determining appropriate immunity test levels for special environments.

The immunity test levels specified for basic safety and essential performance are based on the reasonably foreseeable maximum of the electromagnetic disturbance phenomena in the applicable environments of intended use.

Not all electromagnetic disturbance phenomena are covered by this collateral standard, as it is not practical to do so. Manufacturers of medical electrical equipment and medical electrical systems need to address this during their risk assessment and evaluate if other electromagnetic disturbance phenomena could make their product unsafe. This evaluation should be based on the environments of intended use and the reasonably foreseeable maximum levels of electromagnetic disturbances expected throughout the expected service life.

IEC-60601-1-2 tests recognize that the manufacturer has the responsibility to design and perform verification of medical electrical equipment and medical electrical systems to meet the requirements of this collateral standard and to disclose information to the responsible organization or operator so that the medical electrical equipment or medical electrical system will remain safe throughout its expected service life.

Keystone Compliance assists manufacturers with IEC 60601-1-2 and EN 60601-1-2 test compliance. Please contact us for more information on how Keystone Compliance can assist you with identifying and fulfilling your IEC 60601-1-2 test lab needs.